3 Classification of Tests CDC described the System7 categories were used to classify 1,200 original laboratory tests.A point system was used in each category, 1-3.3 categories were associated with the analyst.3 were associated with the testand one was calibration, QC and proficiency testing.

4 Categories used for ClassificationKnowledgeTraining and ExperienceReagents or Material PreparationCharacteristics of the testing stepsQC, Calibration, Proficiency TestingTrouble Shooting and MaintenanceInterpretation and Judgement of the Analyst.

5 POCT at Pinnacle Health System1996 Merger of 3 hospitals, additional 1 hospital added in 1999.Exception to Section 5.22(f)(to direct more than two laboratories)Inpatient POCTOutpatient POCTTraining/Competency Testing of Resident and Staff Physicians over the last 5 years at ~ 30 out-patient sites and in-patient employed physicians. (200 Practitioners)

6 Regulating Agencies College of American PathologistJoint Commission on Hospital AccreditationState Department of Health.

7 Criteria to Qualify for a PPM LicenseThe examination must be performed by a Physician, Mid Level Practitioner, or a DentistThe procedure must be classified as Moderately ComplexThe microscope must be of the bright field or phase contrast type.The specimen is labile or delay will compromise the accuracy of the test.Control materials are not available for the entire testing process.Limited specimen handling or processing

14 Quality Improvement ProgramCAP STATE JCAHOQC of reagents Same, as Scopes usedincluding stains both agencies should be inInstrument good workingmaintenance order andreview and corrective cleaned and action taken servicedregularly

15 Verifying Accuracy of ResultsCAP STATE JCAHOSame as others How are The lab uses atests with no PT system forevaluated at least verifyingevery 6 months accuracy andfor “unregulated” reliabilitytests? PT, of test resultsbiannual review for tests notprogram, split samples requiring PT testingwith ref lab, or by lawsplit samples in laboratory

16 Reporting of Results CAP STATE JCAHOIs the system for Do test records All results forreporting PPT include the: PPM should beadequate? patient name filed promptlyPatient identifier, or unique identifier, in the patient’stest ordered, date and time of clinical recordPerformed,docs specimen collection, along with the datename or identifier, receipt, reason for and name of analyst.date/time rejection, date of test,of sample collection, identity of analystresult,reference interval,interpretive notes and any additional commentssample quality

18 Twice a year PPMPerformed for first time users, live sample presentation with Dawn, Jenny and myself.Primarily for residents.Every 6 months to assess competency of analyst and for procedure verification.

19 Resident TrainingFirst Year residents in Family Practice and Internal Medicine (key- make it practical and interesting!)Scheduled time with all of them at once.Power Point, slides, “wet samples”.Formalized to include “other parameters”including-CLIA regulations, office practice, technical presentation on PPM, costs of tests, collection of samples, in-depth tour of entire laboratory, predictive value of lab tests.

20 Physician CompetenciesOver 200 performed twice a yearPictures you are seeing are those used.Always have an educational sampleKey-teach themDon’t just satisfy the regs.